Roles & Responsibilities of the position• Ensure regional/global clinical operations deliverables progress according to agreed upon timelines and milestones as leader of the Study Management Team (SMT). Support GTL in managing related CRO activities. This includes country & site feasibility and site selection, trial set-up, study execution and trial closure and vendor set up activities as assigned by the GTL. • Set-up country budgets and monitor actuals vs forecast for Out of Pocket Expenses, and review assigned vendor invoices/spend. • Establish enrolment commitments and ensure actual enrolment meets projected commitments across the regions at the clinical trial level. • Create and update study-specific documents such as Monitoring Guidelines, Informed Consent Form, IMP related documentation, Blinding Plan, country and site feasibility related documents. Provide input into cross functional documents such as Safety related documents, Protocol Deviations and Issue Escalation processes, External Service Provider Oversight Plan, Filing and Archiving Plan. • Create appropriate trial-specific training materials and requirements, making them available to the GCO site study staff and delivering training as needed. Responsible for the set-up and coordination of Investigator Meetings, if applicable, in close collaboration with GCO staff as well as GTL. • Act as the primary contact person for the local teams within GCO. Establish and maintain excellent working relationships with internal stakeholders, including Local Trial Managers. Demonstrates deep knowledge of protocol and procedures and adequate therapeutic area knowledge. • Ensure compliance with global health authority regulations and guidelines and internal operating procedures and processes. Participate in preparation for, and conduct of, Health Authority inspections and internal QA audits. Ensure that the SMT operates in a constant state of inspection-readiness. Work with Quality Management (QM) liaisons to ensure quality oversight of assigned trialJob Requirements• Minimum of 8 years clinical trial management experience in the pharmaceutical industry or CRO, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate's eligibility. • Requires clinical research operational knowledge, strong project planning/management and excellent communication skills, Should be flexible and have experience and ability in managing global or regional teams in a virtual environment. Proven track record in successfully managing trials from start-up to database lock. Experience with supervision of CROs/vendors is preferred. • Ability to operate with limited day to day supervision. Can act as a back-up to the GCDO Trial Leader. Coach and mentor junior staff as needed. • Specific therapeutic area experience may be required depending on the position. • Independent decision-making skills are essential to this role as are analytical skills and effectiveness in seeking solutions to issues. • Effective leadership and delegation skills and proven ability to foster team productivity and cohesiveness. Computer literacy is also required. • Willing to travel up to 20% of time.
• BS degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, and Pharmacy).Remuneration & other detailsLooking for an exciting position in a global company? Do you want to know more.